• 7 months ago
Dave Rosa, President & CEO of NeuroOne, was recently a guest on Benzinga's All-Access.

NeuroOne is a medical device company that designs and manufactures high-definition, minimally invasive thin film electrodes used for intracranial monitoring and ablation. The devices diagnose and treat several neurological conditions like epilepsy and Parkinson's Disease. They are implanted inside the skull to record brain activity. That data helps surgeons better locate and remove the brain tissue causing issues without impacting the rest of the brain.

The company also has a minimally invasive device that can be implanted in the spine, aiming to treat back pain.

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Transcript
00:00Dave, my man, good morning.
00:06Welcome to the show.
00:07Good morning.
00:08Thanks for having me.
00:09You bet.
00:10There's a lot for us to talk about, but for the folks that might not know at home, give
00:14us a quick overview of what is it that your company does.
00:17So NeuroOne makes what we refer to as thin film, high definition electrodes that have
00:27multi-purpose functions, meaning they can perform both diagnostic and therapeutic functions
00:33using the same device.
00:35And we're really focused on pretty much the typical neurosurgical procedures that you
00:40hear about regarding like Parkinson's disease, epilepsy, motor disorders, things like that.
00:47Yeah.
00:48You had a pretty recent announcement of the first implant on the OneRF.
00:53Give us a little bit of insight on what that is and the treatment options there.
00:57Yeah.
00:58So OneRF is the first FDA cleared electrode to perform both diagnostic function as well
01:06as a therapeutic.
01:09We're extremely proud of that.
01:10It's the first device that we've got clearance for that has both diagnostic and therapeutic
01:16functions.
01:17The reason why it's potentially important, at least for physicians, as being a unique
01:24tool in their toolbox is that today when a patient comes in with epilepsy, they perform
01:30a pretty invasive surgical procedure where they implant electrodes.
01:35And the main purpose of that is to find the problem areas in the brain so they could then
01:40target those to do an ablation or a laser procedure.
01:48But after the diagnostic procedure is done, the patient's sent home and then scheduled
01:52for a second surgery where they've got to go back in, drill holes into the skull, implant
01:58a laser, burn the tissue.
02:01And with our device, what we're able to do in the same hospitalization is put the initial
02:07electrodes in for diagnostic purposes.
02:10But then once the neurosurgeon has indicated the problematic areas, instead of having to
02:17send the patient home, re-drill holes, all you need to do, and neurosurgeons want to
02:23do this at the patient's bedside, is all you need to do is to connect the electrode to
02:30our RF generator, and then you can perform the ablation right there without having to
02:37remove any devices or send the patient home.
02:40So much better from a patient's perspective, really only having to go in for one hospitalization
02:47and really one procedure.
02:49And that's kind of like the biggest thing because, I mean, drilling holes, that's already
02:52kind of scary, right?
02:53So having to kind of go through that procedure knowing that, hey, I made it out okay, I made
02:58it out safe, and then to know that, oh, wait, but I've got to go back more, that's just
03:02mentally draining, and that doesn't help when you're trying to recover from such a procedure.
03:06I want to come back to the current activities that you're mentioning here in a second, but
03:10I want to keep expanding on this.
03:13The therapeutic indications with the OneRF, right?
03:16How does it kind of complement what you're already doing, especially the diagnostics
03:19brain mapping technology sector here?
03:22It's really a perfect complement because, again, going back to how these procedures
03:27are staged today, they're staged in that the diagnostic is done first, and then the therapeutic
03:36is done second.
03:37And the beauty of this is that we're using the same device to do both of them.
03:42So it's really the next step, the therapeutic part is the next step in treating the patient
03:48after the diagnostic is done, and being able to use the same device really, really positions
03:53us uniquely in the market.
03:56Now going back to what I was saying earlier, there are a lot of things that you're doing
03:59at the company.
04:00We just talked about one of the major ones.
04:02What else is going on, right?
04:04What else are we doing in the neurological disorder space, and what portfolios are we
04:07targeting?
04:08Yeah.
04:09So in terms of indications, the ones that we're targeting right now, and I already kind
04:17of mentioned some of these, but Parkinson's disease, today probably the most effective
04:22way of treating it, if medications aren't successful, is to use deep brain stimulation.
04:28So again, what we're trying to do is develop the electrode to be implanted permanently
04:34to again, do both diagnostic as well as provide a therapeutic function.
04:41So the diagnostic would be really picking up brain activity that suggests that the patient
04:47may be stumbling or losing their balance, and then in essence, transmitting that information
04:53back to a little pulse generator, which would then stimulate to prevent, hopefully to prevent
05:01the patient from stumbling.
05:04So that's one indication that we're going after, but another application that I think
05:09could be used broadly in the future to treat epilepsy, Parkinson's, really a number of
05:16different diseases, is using our device to deliver gene therapy or drugs to treat patients.
05:24I mean, today, ablation, stimulation are typically used to treat these indications, but there
05:31are a number of studies going on where pharma companies are delivering drugs directly to
05:36the affected area in the brain in the hopes of actually curing these diseases.
05:42So we think that we're positioned very nicely with our electrode because you can use the
05:48electrode again to find the problem area in the brain and then connect it to a system
05:54to deliver the drug, and then after the drug is delivered, really monitor the efficacy.
06:00So we think what the future holds is really different technologies that comprise a large
06:08toolbox for the neurosurgeon, of which I think drug delivery could be the most prominent
06:15when some of these drugs are approved.
06:18We've talked about the brain.
06:19Let's go to another part that is connected.
06:21We'll talk about the spinal cord.
06:23What's unique about it in terms of the stimulation system for NeuroOne?
06:26Yeah, so today, the electrodes that are placed for spinal cord stimulation to treat back
06:33pain, I don't know how well you can see that, but they use electrodes that look like
06:38this, and the reason why they use electrodes like this are you can place them through the
06:44skin.
06:45You can literally place a needle in the target area and then put those types of electrodes
06:50through there.
06:51You can see how small they are, and the contacts of the electrodes are circumferential.
06:58So you're really stimulating in a 360-degree range when you just want to extend stimulation
07:05downward.
07:07So the idea is to take an electrode like this, a flexible electrode like this, roll it up
07:14into a tube and be able to deliver that through a needle and actually have a flat electrode
07:20in there that can stimulate a broader area as well as downward without having to make
07:26an incision in the patient's back.
07:28So the flexibility of our electrodes really allow for something like that to happen, and
07:34that's what makes it unique.
07:36I'll go back to what I said earlier.
07:37The less holes and poking and openings that we have to do, I feel like the better for
07:42the patient and also probably for recovery itself as well.
07:45Let's talk about the temperature control that you provide there as well, especially how
07:49it can kind of enhance patient safety compared to, say, the traditional methods that we might
07:54have used in the past.
07:55Yeah.
07:56What really makes our ablation system or one of the things that makes it unique other than
08:02it can do both diagnostic and therapeutic functions is that we also included a temperature
08:07probe that literally is placed in the center of the electrode.
08:13So the electrode itself has a hollow lumen, and what you can do, what it allows you to
08:18do is actually measure the temperature at the spot where the doctor is ablating the
08:23brain tissue.
08:24I mean, when you're obviously dealing with burning brain tissue, it's a pretty serious
08:30type of procedure.
08:31And you want to make sure the temperature doesn't get too hot.
08:34You don't want to char brain tissue.
08:37You want to do the ablation at a safe temperature really to protect the patient.
08:41And it was something that was important for us to include to really prevent any sort of
08:48issues as this device gets used.
08:50All right.
08:51We've talked about everything that you have done, are doing, but let's talk about the
08:55future.
08:56Any prospects for growth, anything in this sector that we should know about?
08:59What is something we can look forward to here in the future?
09:02Yeah, I think the drug delivery aspect is an area that can really present a lot of growth
09:11for us.
09:12But the other piece is we developed this generator for brain ablation.
09:17But that generator, what we're looking to do is leverage it to perform ablations to
09:22manage pain throughout the rest of the body.
09:25So I think what you'll begin to hear about with the company are additional indications
09:30that we go after to really leverage that system that today is being used for brain ablation.
09:36All right.
09:37Well, hey, I appreciate the insights.
09:39Any final thoughts for me before we go?
09:42Just keep an eye for upcoming news on the company.
09:45We have a lot of things going on.
09:48It's an extremely exciting time for us.
09:50So stay tuned.
09:51All right.
09:52I look forward to it.
09:53Thank you so much for your time.
09:54Thank you.

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